Danish Osteoporosis Prevention Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Fracture
研究概览
简要总结
Hypothesis: Use of hormone replacement therapy (HRT) decreases the incidence of fractures in early postmenopausal women.
The project was initiated in 1990, and the inclusion ended in 1993. A total of 2,016 early postmenopausal women were divided into two groups: The first group accepted randomisation to HRT or not, and the second group was allowed to choose HRT or not.
The study was not blinded. Main measurements were fracture risk over 20 years, changes in bone mineral density over 20 years, and side effects, mainly breast cancer.
详细描述
Aim: To study the ability of hormone replacement early after menopause on risk of fractures and changes in bone mineral density, and side effects.
The project was designed as a comprehensive cohort trial. One group accepted randomisation, and was randomised to hormone replacement therapy (HRT) or not (no placebo used).
502 were randomised to HRT, and 504 were randomised to no HRT) One group was allowed to choose HRT or not. A total of 221 chose HRT, and 789 chose no HRT.
First line HRT was oral sequential oestradiol/norethisterone in women with intact uterus and oral continuous oestradiol in hysterectomised women.
The study was initiated in 1990, and inclusion ended in 1993.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 58 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 45-58 years with an intact uterus
- •Three to 24 month past last menstrual bleeding
- •Hysterectomised women aged 45-52 years and having elevated FSH
排除标准
- •Metaboliv bone disease including osteoporosis defined as non-traumatic vertebral fractures on X-ray
- •Current estrogen use or estrogen use within the past three month
- •Current or past treatment with glucocorticoids for more than 6 month
- •Current or past malignancy
- •Newly diagnosed or uncontrolled chronic disease
- •Alcohol or drug addiction
结局指标
主要结局
Fracture
Bone mineral density
次要结局
- Menopausal symptoms
- Breast cancer